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Quality Engineer Medical Device Jobs in Colorado

Sr Quality Design Engineer

Westminster, CO · On-site

$89K - $121K/yr

Sr Quality Design Engineer Principal Duties and Responsibilities: Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

Sr Quality Design Engineer

Westminster, CO · On-site

$89K - $121K/yr

Sr Quality Design Engineer Principal Duties and Responsibilities: • Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

Quality Engineer

Fort Collins, CO · On-site

$75K - $110K/yr

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

Quality Engineer

Fort Collins, CO · On-site

$71K - $91K/yr

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

Quality Engineer

Fort Collins, CO

$71K - $91K/yr

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

Desgin Quality Engineer

Boulder, CO · On-site

$74K - $96K/yr

Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive ... Understanding of Object Oriented programming techniques Working knowledge of C# Working knowledge ...

... medical device environment. This role serves as the central point of accountability for program ... Influence without direct authority across engineering, quality, supply chain, and external partners.

Showing results 21-40

Quality Engineer Medical Device information

See Colorado salary details

$22

$38

$74

How much do quality engineer medical device jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for quality engineer medical device in Colorado is $38.61, according to ZipRecruiter salary data. Most workers in this role earn between $26.06 and $48.27 per hour, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
What are the most commonly searched types of Quality Engineer Medical Device jobs in Colorado? The most popular types of Quality Engineer Medical Device jobs in Colorado are:
What are popular job titles related to Quality Engineer Medical Device jobs in Colorado? For Quality Engineer Medical Device jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Quality Engineer Medical Device jobs in Colorado look for? The top searched job categories for Quality Engineer Medical Device jobs in Colorado are:
What cities in Colorado are hiring for Quality Engineer Medical Device jobs? Cities in Colorado with the most Quality Engineer Medical Device job openings:
Infographic showing various Quality Engineer Medical Device job openings in Colorado as of August 2026, with employment types broken down into 93% Full Time, and 7% Contract. Highlights an 100% In-person job distribution, with an average salary of $80,319 per year, or $38.6 per hour.

Clinical Engineering Medical Device Security Engineer II

CommonSpirit Health

Englewood, CO

$49.78 - $82.14/hr

Full-time

Re-posted 3 days ago


CommonSpirit Health rating

7.0

Company rating: 7.0 out of 10

Based on 531 frontline employees who took The Breakroom Quiz

417th of 887 rated healthcare providers


Job description


Job Summary and Responsibilities

As our Clinical Engineering Medical Device Security Engineer II, you will be a key architect of CommonSpirit Health's robust medical device cybersecurity framework, providing advanced expertise to safeguard patient safety and device integrity across the system. This senior role involves not only mitigating vulnerabilities but also proactively designing and implementing cutting-edge security solutions and evaluating the effectiveness of controls. You will be instrumental in developing and delivering critical security tool and process training, ensuring our teams are equipped to handle the evolving cyber threat landscape.

Every day you will lead collaborations with cross-functional teams to architect innovative security solutions that harden technical controls for network-connected medical devices, all while meticulously preserving device functionality and patient safety. This includes expertise in areas like network architecture, Active Directory, group policies, Windows images, and endpoint security tools. You will continuously leverage advanced technology and analytical insights to evaluate the efficacy of existing security controls, recommending strategic adjustments and enhancements to bolster our defenses. Furthermore, you will provide system-wide medical device security training, troubleshoot complex issues, and expertly lead recovery efforts for devices impacted by upgrades, patching, or security incidents, embodying all the responsibilities of the Medical Device Security Engineer I role.

To be successful in this pivotal role, you will possess significant experience in medical device security engineering, cybersecurity architecture, and system-level vulnerability management. Your expertise in incident response, forensics, and the development of secure medical device environments will be crucial. We are seeking a highly skilled and strategic professional with a proven track record in developing and implementing advanced security solutions without compromising operational integrity. Strong communication and training capabilities are essential, along with a deep understanding of relevant cybersecurity regulations and the ability to conduct comprehensive risk assessments and remediation strategies.

  • Architect and implement robust security solutions for networked medical devices
  • Continuously evaluate and enhance existing security controls against evolving threats
  • Provide system-wide medical device security training
  • Lead troubleshooting and recovery efforts for affected medical devices
  • Mitigate vulnerabilities and lead incident response for medical device security
  • Conduct comprehensive security assessments and ensure regulatory compliance

The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned.

Job Requirements

Required:

  • Bachelors degree in HTM, Computer Science, Technology or Business Discipline upon hire or equivalent professional experience required. 
  • 4-7 years of experience working in healthcare/IT Security, System Administration, Software Development or related field.
  • 2-5 years experience working in a healthcare/medical environment.
  • Experience working with specialized medical equipment in a healthcare setting.
  • Experience with Cybersecurity and Infrastructure Security Agency (CISA) HIPAA/HITECH compliance standards.
  • Valid Driver's License

Preferred:

  • Experience working with the software development life cycle or project management methodologies preferred
  • Certified Biomedical Equipment Technician (CBET)
  • Certified Radiology Equipment Specialists (CRES)
  • Certified Healthcare Tech Manager (CHTM)
  • CompTIA A+ Certification (A-PLUS)
  • CompTIA Network A+ (NTWK-PLUS)

This position requires participation in a rotational on-call schedule, including nights, weekends, and holidays. Candidates must be available to respond to urgent service needs outside of regular business hours and may be required to return to the facility on short notice.

Where You'll Work

Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation’s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.


Pay Range
$49.78 - $82.14 /hour

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